Nociception Index Level (NOL) Perioperative Monitoring During Regional Anesthesia

Recruiting

• Conditions: Intraoperative Monitoring; Pain; Regional Anesthesia

• Registration Number: NCT06300606
• Lead Sponsor: American Hospital of Paris

Brief Summary

This prospective observational study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb. We included 50 consecutive adult patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia. The locoregional anesthesia was performed under ultrasound, with or without neurostimulation. Intraoperative pain is assessed using NOL index monitoring, ALGISCORE and Numerical Scale, and second point study is the midazolam and propofol requirement.

Detailed Description

Introduction: Intraoperative pain assessment is difficult and based on indirect parameters of sympathetic-parasympathetic system stimulation. Recently, the Nociception Level index (NOL™) providing a value from combination of multiple physiological parameters to measure pain has been developed to enable intraoperative pain monitoring during general anesthesia. While this monitoring has also been used postoperatively in awake patients, data are scarce to assess pain under locoregional anesthesia. This study was conducted to assess pain using NOL index under locoregional anesthesia for orthopedic surgery of the upper limb.

Method: 50 consecutive patients scheduled for orthopedic surgery of the upper limb under locoregional anesthesia were included. Exclusion criteria were emergencies, request for general anesthesia, and patients under 18 years of age. All patients were informed and consented to the technique of locoregional anesthesia and pain monitoring without change of practice. After premedication with oral hydroxyzine, locoregional anesthesia was performed under ultrasound, with or without neurostimulation. Monitoring began as soon as the venous infusion was started, and parameters were recorded at the time of locoregional anesthesia, tourniquet inflation, surgical incision, skin closure and dressing.

Pain is also assessed using the ALGISCORE by the nurse and the numerical scale (0 to 5) and satisfaction score at the end of the procedure. The need to administer midazolam or propofol at the anesthetist's discretion is noted, as is the effectiveness of locoregional anesthesia (conversion to general anesthesia). Data were analyzed using Friedman and Mann-Whitney tests.

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-03
• Study Start: 2024-03-05
• Study First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Study First Posted: 2024-03-08
• Last Update Posted: 2024-03-08
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

scheduled upper limb orthopedic surgery under regional anesthesia

Exclusion Criteria

Patient less than 18 years old emergency surgery patient refusal of regional anesthesia chronic neurocognitive disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain score	intraoperative	ALGOPLUS pain scale

Secondary Outcome Measures

Name	Time	Method
sedative requirement	intraoperative	propofol
anxiolytic requirement	intraoperative	midazolam
failure of regional anesthesia	intraoperative	general conversion or sufentanil requirement

Trial Locations

Locations (1)

Gilles BOCCARA; 🇫🇷 Neuilly-sur-Seine, France